Improving Consent Experiences in Clinical Trials

NCT07293520 | Withdrawn

• 1 other identifier: 202511065
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.

Conditions

Cancer

Keywords

Informed Consent; Key information; Research Ethics

Outcome Measures

Primary Outcomes (2)

• Patient's knowledge of consent

  Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests.

  Time of consent completion for parent study (day 1)

• Patient's anxiety about enrolling

  Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests.

  Time of consent completion for parent study (day 1)

Secondary Outcomes (3)

• Patient's trust in information

  Time of consent completion for parent study (day 1)

• Patient's perceptions of patient centered care

  Time of consent completion for parent study (day 1)

• Parent study enrollment rates

  Completion of enrollment (estimated total time is 9-13 months)

Study Arms (3)

Standard consent forms

ACTIVE COMPARATOR

The approved standard consent form will be used during the consent processes.

Behavioral: Standard Consent Form

Standard consent forms with a visual key information (VKI) page

EXPERIMENTAL

The approved standard consent form with a VKI page will be used during the consent processes.

Behavioral: Standard Consent Form; Behavioral: Visual Key Information (VKI) page

Research Team Members

EXPERIMENTAL

Members of the parent study's research team will complete the research team survey to assess opinions on consent process.

Behavioral: Standard Consent Form; Behavioral: Visual Key Information (VKI) page

Interventions

Standard Consent Form BEHAVIORAL

The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.

Research Team Members; Standard consent forms; Standard consent forms with a visual key information (VKI) page

Visual Key Information (VKI) page BEHAVIORAL

A VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study.

Research Team Members; Standard consent forms with a visual key information (VKI) page

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Patient Eligibility Criteria: * Patient must be 18 years or older * Patients must be English-speaking * Able to understand an IRB-approved written consent document * Must go through the consent process for one of the parent studies Research Team Eligibility Criteria: * Member of a parent study research team * Engaged in the study consent processes, including creating and reviewing consents or enrolling participants

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Neoplasms

Interventions

Electrophoresis, Polyacrylamide Gel

Intervention Hierarchy (Ancestors)

Electrophoresis; Chemistry Techniques, Analytical; Investigative Techniques; Electrochemical Techniques

Study Officials

• Mary C Politi, PhD

  Washington University in St. Louis School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 19, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share